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  • Water Exchange and CO2 Insufflation with Abdominal Compression Device to Reduce Manual Assistance

    This will be a three-arm multicenter parallel randomized controlled trial (RCT) designed to compare the frequency of ancillary manual assistance (abdominal pressure and/or position change) between CO2-insufflation colonoscopy with Maxbelt (intervention group), CO2-insufflation colonoscopy with sham device (sham control group), and water exchange (WE) colonoscopy (WE group). Enrolled patients will be randomized in a 1:1:1 ratio to either the intervention, sham control, or WE group. This will be a comparison of three different methods (CO2 with interventional device, CO2 with sham device, WE) to see which one is better at decreasing the need for manual assistance by endoscopy staff during colonoscopic insertion. This study will be conducted in two hospitals in Taiwan: Evergreen General Hospital at Taoyuan and E-Da Dachange Hospital at Kaohsiung. The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA will be a non-recruiting participating site. This planned RCT will span 30 months (from June 2024 to November 2026), including 3 months for the initial setup and 3 months for the final analysis. The study site possesses state-of-the-art colonoscopy equipment setups, and the investigators are WE colonoscopy research experts. Patients aged 45-75 y/o at average risk of colorectal cancer who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified by investigator and type of colonoscopy (screening, surveillance, or positive fecal immunochemical test result). Mode of sedation will include conscious sedation (fentanyl plus midazolam) or full sedation (propofol with fentanyl plus midazolam) . Randomization will be carried out by computer-generated sequences using a block design (four participants per block). CO2 with interventional device group: The Maxbelt will be applied around the circumference of the lower abdomen just below the umbilicus based on patient's abdominal circumference. Five sizes of Maxbelt will be employed in this study: XS-size for 55-65 cm circumference, S-size for 65-75 cm circumference, M-size for 75-85 cm circumference, L-size for 85-95 cm circumference, and XL-size for 95-105 cm circumference. Once applied, participants will be asked to assess and confirm that the belt is fastened tightly but not uncomfortably. CO2 with sham device group: A two-size larger Maxbelt with loose fitting will be used as a sham device: L-size will be used for 55-71 cm circumference, XL-size will be used for 72-88 cm circumference, and 2 XL-size will be used for 89-105 cm circumference. WE group: The air pump will be turned off during the insertion phase of colonoscopy, while the colon is irrigated with warm-to-touch distilled water or half normal saline using a flushing pump. The WE approach involves the simultaneous infusion of water to facilitate luminal expansion and suction of unclean water during insertion.

    Phase

    N/A

    Span

    109 weeks

    Sponsor

    Evergreen General Hospital, Taiwan

    Kaohsiung

    Recruiting

    Healthy Volunteers

  • Metformin for the Treatment of MCRC Patients Undergoing FOLFIRI Plus Target Therapy

    Objectives: 1. Main purpose • To investigate progression-free survival (PFS) in patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin 2. Secondary purpose (1) To investigate the survival (OS) of patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin (2) To investigate the disease control rate (DCR) of patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin

    Phase

    2

    Span

    166 weeks

    Sponsor

    Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung

    Recruiting

  • Bioimpedance Analysis for Hemodialysis

    The goal of this clinical trial is to learn if bioimpedance-guided fluid management can decrease major adverse cardiovascular events (MACE), symptoms during hemodialysis, or other important outcomes such as vascular access patency, fluid overload admissions, etc. in maintenance hemodialysis patients. The main questions it aims to answer are: Hypothesis 1: bioimpedance-guided fluid management decreases MACE Hypothesis 2: bioimpedance-guided fluid management decreases intradialytic hypotension, cramps and fatigue Hypothesis 3: bioimpedance-guided fluid management decreases need for urgent revascularization of vascular access for hemodialysis Participants in the control group will decide their target weight according to physician's suggestion and the patient's preference, according to symptoms that are thought related to fluid status aberrancy (for example, edema, crackles for fluid overload, and cramps, intradialytic hypotension, fatigue for fluid insufficiency, given no other acute illness accountable for the symptoms and intradialytic weight gain not exceeding 5% of previous weight) Participants in the active (bioimpedance) group will adjust their dry weight as those in the control group, if symptoms of fluid status aberrancy present. However, if no symptoms occur, they will receive adjustment according to measurements by bioimpedance analysis.

    Phase

    N/A

    Span

    87 weeks

    Sponsor

    Cishan Hospital, Ministry of Health and Welfare

    Kaohsiung

    Recruiting

  • A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)

    Phase

    2

    Span

    142 weeks

    Sponsor

    GlaxoSmithKline

    Kaohsiung

    Recruiting

  • Evaluation of BTV100 in Subjects With Dry Eye Disease

    At the screening visit/Visit 1 (Day 1 minus 14 days), subjects who are eligible according to the inclusion and exclusion criteria will begin a 14-day run-in period during which they will self-administer 1 drop of single-masked vehicle to each eye twice daily (BID), morning and evening (at least 6-hour interval). At the time of the screening visit/Visit 1, subjects will be instructed to discontinue all over the counter (OTC) and prescription topical ophthalmic medications except for the vehicle or study drug throughout the study. At Baseline/Visit 2 (Day 1), subjects who continue fulfilling inclusion/exclusion criteria will be randomized to study drug or vehicle. Approximately120 subjects will be randomized. Subjects will be randomized to one of the following 4 treatment groups. Following randomization, subjects being masked to treatment assignments will be instructed to self-administer 1 drop of investigational product (IP) into each eye twice daily, morning and evening (at least 6-hour interval). Subjects will be instructed to return to the clinic to be evaluated at Day 15 (Visit 3), Day 29 (Visit 4), Day 57 (Visit 5), and Day 85 (Visit 6).

    Phase

    2

    Span

    59 weeks

    Sponsor

    BioTheraVision, Inc.

    Kaohsiung

    Recruiting

  • The Effect of Melatonin Supplementation on Cumulus Cells and IVF Outcomes

    Aging in female reproductive cells, particularly cumulus granulosa cells, is associated with various dysfunctions that compromise fertility. Melatonin, a hormone primarily produced by the pineal gland, is renowned for its multifaceted roles in regulating physiological processes, including sleep-wake cycles, immune function, and antioxidative defense. Melatonin's antioxidant action is mediated through direct scavenging of free radicals, upregulation of antioxidant enzymes, and improvement of mitochondrial efficiency. These properties make melatonin a promising candidate for mitigating the adverse effects of aging on cellular function. This study aims to explore the effects of melatonin supplementation on cumulus cell gene expression and in vitro fertilization (IVF) outcomes in women over 35 years old. In the study group, patients will receive melatonin supplementation for at least two months prior to their IVF cycles. In the control group, patients will proceed directly to IVF cycles without melatonin supplementation. Cumulus cells will be collected after oocyte retrieval, and gene expression will be measured. Additionally, clinical pregnancy rate, live birth rate, and miscarriage rate between the two groups will be evaluated.

    Phase

    N/A

    Span

    244 weeks

    Sponsor

    Kaohsiung Veterans General Hospital.

    Kaohsiung

    Recruiting

  • A Randomized Trial Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Over-Expressed Refractory Metastatic Colorectal Cancer

    Phase

    3

    Span

    234 weeks

    Sponsor

    AbbVie

    Kaohsiung

    Recruiting

  • A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features

    The primary objective of the study is to assess the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig relative to SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

    Phase

    3

    Span

    536 weeks

    Sponsor

    AstraZeneca

    Kaohsiung

    Recruiting

  • A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis

    Phase

    3

    Span

    148 weeks

    Sponsor

    Amgen

    Kaohsiung

    Recruiting

  • AZD0486 as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL

    This is a modular, Phase II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of AZD0486 monotherapy administered as an intravenous (IV) infusion in participants with relapsed or refractory B-NHL. The purpose of this study is to determine the efficacy and safety of AZD0486 administered at the RP2D in adults 18 to 80 years of age with relapsed or refractory B-NHL.

    Phase

    2

    Span

    238 weeks

    Sponsor

    AstraZeneca

    Kaohsiung

    Recruiting

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